Scientific Expert

vor 1 Tag

Basel, Schweiz F. Hoffmann-La Roche Gruppe Vollzeit

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for future generations. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

The Opportunity
As Roche’s future product portfolio demands more and more device capabilities and product solutions, we are investing in our industrialization and sustaining engineering capabilities by strengthening and expanding our Device capabilities. We are looking for a highly skilled and experienced senior technical and strategic manager leading those efforts, embedded within the Global MSAT (Manufacturing Science & Technology) organization.

We seek a highly skilled and motivated Scientific Expert to join our team as an Analytical Lead for method transfers and validations at commercial manufacturing sites. This role is pivotal in implementing robust analytical science and technology and ensuring high-quality standards for controlling and testing starting materials, intermediates, drug substances, and products manufactured by CDMOs for Roche. Your key responsibilities will be:

  • Serve as the analytical lead for method transfers and validations at the manufacturing sites
  • Act as the person-in-plant during critical project phases, including validation and registration preparation
  • Support manufacturing sites during the preparation for pre-approval inspections to ensure compliance with regulatory requirements
  • Collaborate with CMC groups at each drug substance and drug product site, late-stage technical development, and commercial quality control teams to facilitate analytical technology transfers
  • Author and review technical reports, analytical validation documents, and regulatory submissions to accelerate product industrialization and drive commercial product life cycle management
  • Lead and contribute to cross-site and cross-functional teams responsible for technical oversight of drug substance and drug product manufacturing, quality issue resolution, and product improvement
  • Contribute to the development and implementation of Process Analytical Technologies (PAT), driving innovation and excellence in analytical methodologies

Who you are

  • An advanced degree in Analytical Chemistry, Chemistry, or a related scientific discipline
  • Extensive experience in analytical method development and transfers in a commercial manufacturing environment
  • Strong knowledge of GMP and regulatory requirements for drug substance and drug product manufacturing
  • Excellent collaboration and communication skills to work effectively with cross-functional and cross-site teams
  • A proactive mindset with a focus on quality, compliance, and innovation

Additional Information:

  • This role may require travel to CDMO manufacturing sites (20%)
  • Flexibility to work outside regular business hours may be needed to accommodate international collaborations and project timelines

Are you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be an outstanding opportunity to craft the future of Roche.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche's largest sites. Read more.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.

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